The UK’s regulatory offer: how do we best use regulation to create the breakthroughs people need?

The ABPI’s Executive Director Regulatory Dr Dan O’Connor reflects on the ABPI’s recent Regulatory Science Symposium discussions.

At our Regulatory Science Symposium last week, we set ourselves a simple question. How can the UK make the most of its regulatory framework, so that patients get the medicines they need as quickly as possible?

There is a shared ambition across our sector. We all want the UK to be the best place in the world to research, develop and use innovative medicines and health technologies.

Regulation is a critical part of achieving that ambition, and in many cases, regulation is the front door to the UK life sciences ecosystem. Good science and flexible, pragmatic regulation can drive innovation. Together, they give companies the clarity needed to try new approaches.

At the symposium, we heard how the Regulatory Innovation Office (RIO), the Advanced Research + Invention Agency (ARIA) and LifeArc are helping to clear the path for new technologies. We also heard how the Medicines and Healthcare products Regulatory Agency (MHRA) is shaping its routes to market and building international partnerships. Interest is growing in its aligned pathway with the National Institute for Health and Care Excellence (NICE).

But the discussion I keep coming back to is about what makes the UK’s regulatory offer stand out.

Where does the UK stand? 

My ABPI colleague Jas Dhaliwal-Rahi shared early findings from our work comparing regulatory innovation across nine markets.

Our initial analysis, shows the UK has real strengths, including flexible licensing routes and growing global partnerships.

However, one of the biggest risks Jas identified is that the UK’s offer is crowded and there is opportunity to provide a clearer narrative. Our emerging recommendations are that the UK should:

·   choose and communicate where it will lead

·   bring its routes together into a simpler offer

·   concentrate on fewer regulatory science niches

·   strengthen its operational foundations

An ecosystem, not a niche

One of our MHRA speakers offered a complementary view, setting out the agency’s international strategy since the UK left the EU. Reliable day to day performance is the foundation. It is what makes innovation and international collaboration possible. International partnership has become central, as shown by:

·   new roles embedding MHRA and US Food and Drug Administration staff in each other’s organisations

·   a renewed Access Consortium

·   the UK-Singapore innovation corridor

The MHRA also posed a constructive challenge to our analysis. If the UK picks one or two niches, other regulators will almost certainly pick the same ones. The alternative is an ecosystem that works for any type of innovation.

Both approaches have merit, and the answer may lie in combining them. That means a clear, well-communicated offer, built on an ecosystem that works from end to end.

What the panel told us

In an industry-led panel, a patient advocate reminded us what early access means for families. It means access from the moment data shows a medicine works and is safe. It does not mean months later. Waiting four years for an approved treatment is a very long time when life expectancy is around 20 years.

Panellists from industry, the cell and gene therapy sector and the MHRA agreed the regulator is only one part of a wider system. Predictability and reliability shape decisions about where to launch. Complex, personalised medicines need a less linear approach. And no single body owns the whole problem. That is why political leadership and accountability matter. The MHRA announcement of £20 million for four new Centres of Excellence in Regulatory Science and Innovation added to the momentum of the discussions.

Where next?

The UK has all the tools needed to lead the world in regulation - the science, the ambition and a strong independent regulator.

What we need now is a regulatory offer that is clear, joined up with Health Technology Assessment and the NHS, and designed around patients. We will finalise our international work in the coming months. I look forward to continuing these conversations across the system.